Post-Market Clinical Trial of Neurorehabilitation With Mindlenses in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Global Cognitive Function Change Over Time
研究概览
简要总结
This study aims to describe the use of MindLenses, a rehabilitation device that integrates prism adaptation with serious game-based cognitive exercises, in individuals undergoing cognitive rehabilitation after stroke. The intervention consists of structured sessions combining visuomotor recalibration and gamified cognitive tasks designed to target domains such as attention, visuospatial processing, and executive functions. The study examines changes in cognitive performance across the intervention period and documents the characteristics of the training program. The objective is to provide a detailed description of the implementation of MindLenses in a clinical rehabilitation setting and to characterize the cognitive domains addressed through the combined prism-adaptation and game-based approach.
详细描述
This clinical investigation aims to evaluate the safety and effectiveness of the MindLenses system, a medical device integrating prism adaptation with serious game-based cognitive training for post-stroke rehabilitation. The study includes two groups: an experimental group receiving the MindLenses intervention and a control group receiving standard cognitive and motor rehabilitation. The investigation focuses on device safety, changes in cognitive and motor performance, and measures related to usability and procedural feasibility.
Intervention Description:
The MindLenses intervention consists of a structured treatment session combining a prism-adaptation phase with adaptive serious games. During prism adaptation, participants perform visuomotor tasks under optically deviated vision to promote sensorimotor recalibration. The subsequent serious game phase provides exercises targeting attention, visuospatial abilities, executive functions, memory, and processing speed, with automatic difficulty adjustment based on performance. Sessions are delivered under therapist supervision and follow a standardized protocol.
Participants in the control group undergo standard clinical cognitive and motor rehabilitation, including paper-and-pencil tasks, visuospatial scanning, problem-solving activities, and conventional motor therapy. No prism-adaptation or serious-game elements are used in the control arm.
Assessments and Follow-Up:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria
- •Inclusion Criteria:
- •First ischemic or hemorrhagic stroke, with a minimum interval of 30 days from the acute event
- •Presence of cognitive deficits identified during the pre-treatment neuropsychological assessment
- •Ability to understand and sign informed consent and willingness to participate in follow-up assessments
- •Age ≥ 18 years
排除标准
- •Upper limb motor impairments preventing the use of a tablet
- •Severe visual deficits affecting stimulus perception
- •Concurrent neurological or psychiatric disorders
- •Substance abuse
- •Diagnosis of dementia
- •Severe Wernicke's aphasia
- •Age > 80 years
结局指标
主要结局
Global Cognitive Function Change Over Time
时间窗: Baseline, immediately after completion of treatment, 3-month follow-up, and 6-month follow-up
Primary outcomes are changes in performance across a neuropsychological battery at baseline, post-treatment, 3- and 6-month follow-up. Measures include: Oxford Cognitive Screen (0-30), Raven's CPM (0-36), Digit Span (0-8), Corsi Block-Tapping (0-8), Rey 15-Word Test immediate (0-75) and delayed (0-15), Rey-Osterrieth Figure (0-36), Matrici Attentive (accuracy), Stroop interference (lower=better), Line Bisection deviation (lower=better), Bells Test (0-35), BADA Naming (accuracy), Phonemic and Semantic Fluency (correct words/60s), Copy of Drawings with (0-70) and without programming elements (0-12), VOSP (subtest scores), Buccofacial Apraxia Test (performance score). Higher scores indicate better performance unless noted.
次要结局
未报告次要终点